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This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma
This study will be a phase 4 open label interventional case series. Patients with retinoblastoma will be receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive chemotherapy on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 18 months .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEV with/without carboplatin | Experimental | CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin periocular injection | Drug | chemotherapy together with/without 20mg/2ml carboplatin periocular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival Rate | measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huasheng Yang, M.D, PHD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Study Chair |
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Exclusion Criteria:
Object: Stage II or IIIa base on International Retinoblastoma Staging System dates: January 2009- February 2014 location: Zhongshan Ophthalmic Center
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| ID | Title | Description |
|---|---|---|
| FG000 | CEV With/Without Carboplatin | CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CEV With/Without Carboplatin | CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event Free Survival Rate | measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis | Posted | Number | participants | 18 months |
|
up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CEV With/Without Carboplatin-Stage 2 | CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| central nervous system metastasis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Huasheng Yang | Zhongshan Ophthalmic Center, Sun Yat-sen University | +862087331539 | yanghs64@126.com |
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| ID | Term |
|---|---|
| D012175 | Retinoblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D014750 | Vincristine |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
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| CEV chemotherapy | Drug | vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2 |
|
|
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Participants | Number | participants |
|
|
|
|
| 2 |
| 9 |
| 0 |
| 9 |
| EG001 | CEV With/Without Carboplatin-Stage 3 | CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2 | 13 | 17 | 0 | 17 |
| Orbit Relapse | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| central nervous system metastasis and orbit relapse | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019572 | Retinal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |